Documents
Briefs, oral arguments, agency decisions and the Federal Register.
5,436 results
0.11s
Federal Register · Notice · May 2, 1997
DATES: Written comments by June 16, 1997. … FDA has such authority under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301 et seq., and the Public Health Service Act, 42 U.S.C. 201 et seq.
62 FR 24320Timing of Nonclinical Studies for the Conduct of Human Clinical TrialsHealth and Human Services DepartmentFederal Register · Notice · May 19, 2015
After the comment period is closed, nominations to add or remove bulk drug substances from the list may be submitted to FDA by citizen petition under § 10.30 (21 CFR 10.30). … Follow the instructions for submitting comments.
80 FR 28622Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 9, 2012
Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act … These letters are included in PCPC/CHPA's comment.
77 FR 27230Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 11, 2026
ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. … Existing records may be used if they contain all the required information and are retained for the required time period.
91 FR 35486Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 18, 2023
ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. … Responsible persons are required to maintain records related to each report of an adverse event for a period of 6 years (or 3 years for a small business that does not manufacture or process certain cosmetic
88 FR 63960Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 9, 2015
for public comment in response to the notice. … Some respondents send in requests as often as three or four times a month while others may submit only periodic requests.
80 FR 1422Health and Human Services DepartmentFood and Drug AdministrationMedication Guides: Patient Medication Information
Federal Register · Proposed Rule · May 31, 2023
Submit written comments (including recommendations) on the collection of information under the Paperwork Reduction Act of 1995 by November 27, 2023. … ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered.
88 FR 35694Health and Human Services DepartmentFood and Drug AdministrationFood Additives Permitted in Feed and Drinking Water of Animals; Formic Acid
Federal Register · Rule · Feb 9, 2011
Follow the instructions for submitting comments. Written Submissions Submit written objections in the following ways: Fax: 301-827-6870. … The notice of filing provided for a 30-day comment period on the petitioner's environmental assessment. One comment was received that was not substantive. II.
76 FR 7106Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 11, 1999
This notice is issued under the Controlled Substances Act. … The short time period for the submission of comments and requests for a public meeting is needed to assure that HHS may, in a timely fashion, carry out the required action and be responsive to the United
64 FR 1629Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Nov 28, 1997
The proposal gave the public 30 days to submit written comments. The comment period later was reopened for an additional 2 weeks (see 61 FR 11349, March 20, 1996). … Comments relied on the recent Ninth Circuit decision, Papike, to support their interpretation of Medtronic and the scope of preemption under 521(a) of the act.
62 FR 63271Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Exemptions From Premarket Notification; Class II Devices
Federal Register · Rule · Nov 15, 2001
This section requires FDA to publish in the Federal Register a notice of intent to exempt a device, or of the petition, and to provide a 30-day comment period. … FDA received no comments.
66 FR 57368Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 22, 2005
Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed … FDA estimates a 2-year time period during which these requests will be made following the issuance of this guidance.
70 FR 70621Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Sep 20, 2024
Legal Authority FDA is taking this action under the general administrative provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act). … of Benefits, Costs and Distributional Effects of Proposed Rule Category Primary estimate Low estimate High estimate Units Year dollars Discount rate (%) Period
89 FR 77062Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 27, 2014
The comment stated that the Food Safety Modernization Act (FSMA) gave FDA authority “to require producers to implement prevention based food safety standards.” … The comment also noted the periodic scheduling of audits and inspections of hospitals by the regulator.
79 FR 4350Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Exemptions From Premarket Notification; Class II Devices
Federal Register · Rule · Jan 8, 1999
This section requires FDA to publish in the Federal Register a notice of intent to exempt a device, or of the petition, and to provide a 30-day comment period. … FDA received no comments.
64 FR 1123Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 18, 2009
There will also be an opportunity for general attendees to provide feedback on the discussion topics during periodic open sessions. … Jeffrey Shuren, Acting Director, Center for Devices and Radiological Health. [FR Doc. E9-30114 Filed 12-17-09; 8:45 am] BILLING CODE 4160-01-S
74 FR 67237Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 23, 2022
The comment period for the July 2020 notice was reopened for 30 days on January 8, 2021 (86 FR 1515), to allow interested parties an additional opportunity to comment. … The comment period for the July 2020 notice was reopened for 30 days on January 8, 2021 (86 FR 1515), to provide interested parties an additional opportunity to comment before FDA began to develop its
87 FR 71642Health and Human Services DepartmentFood and Drug AdministrationFood Labeling: Revision of Reference Values and Mandatory Nutrients
Federal Register · Proposed Rule · Nov 2, 2007
On March 1, 2004 (69 FR 9559), FDA reopened the comment period for the 2003 trans fat ANPRM to receive comments that considered the information in the 2003 IOM report on nutrition labeling (Ref. 16 … On April 19, 2004 (69 FR 20838), FDA extended the comment period for the 2003 trans fat ANPRM to receive comments that considered the information in the 2004 subcommittee meeting (Ref. 23) that addressed
72 FR 62149Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Nov 28, 2012
FDA seeks comment on the following issues related to section 918(a)(2) of the FD&C Act: 2.1. … FDA seeks comment on the following issues related to section 918(a)(3) of the FD&C Act: 3.1.
77 FR 70955Health and Human Services DepartmentFood and Drug AdministrationSubstances Prohibited From Use in Animal Food or Feed; Confirmation of Effective Date of Final Rule
Federal Register · Rule · Apr 24, 2009
April 9, 2009 (74 FR 16160) (referred to herein as the April 9, 2009, proposal), FDA published a proposal that would delay the effective date of the April 25, 2008, final rule for 60 days and provided a period … FDA has consulted with the Environmental Protection Agency (EPA) on this issue and EPA has recently published a statement on its Web site stating that, under the Resource Conservation and Recovery Act
74 FR 18626Health and Human Services DepartmentFood and Drug Administration
Ask Donna what matters in the record.
She can read the source against your case and show you exactly where the answer came from.